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Ethics in non-medical research
Karen Schafheutle PhD
Research Practice and Governance Co-ordinator
The University of Manchester
Combining the strengths of UMIST and
The Victoria University of Manchester
Outline
• Ethics
– what is it?
– Why is it relevant to non-medical research?
• Best practice standards
– Current set-up at UoM and proposed changes
• Best practice - standards into practice
– Challenges of local implementation
• Questions
Combining the strengths of UMIST and
The Victoria University of Manchester
Research ethics = medical ethics?
Ethics =
• The science of human duty
• The body of rules of duty drawn from this science
• A particular system of principles and rules concerning
duty, whether true or false; rules of practice in respect
to a single class of human actions.
Combining the strengths of UMIST and
The Victoria University of Manchester
Research ethics = medical ethics?
•
1930s A mistake in the formulation of a children's syrup (sulphanilamide in ethylene glycol)
of deaths and led the FDA (US) to set up a product authorisation system
•
1947 Nuremburg Code (Directives for Human Experimentation)
•
1950s Japanese government regulated sale of medicinal products
•
1960s Effects of thalidomide synthetic drug triggered review of practices in Europe
•
1964 Declaration of Helsinki
•
1968 Medicines Act (UK)
•
1989 WHO Conference of Drug Regulatory Authorities produced action plans for regulation of
medical research
•
1990 First ICH meeting held between EU, Japan and US regulatory authorities to harmonise practices
•
1996/97 ICH Guidelines on Good Clinical Practice
•
2001 EU Directive on Clinical Trials (2001/20/EC)
•
2001 Research Governance Framework for Health and Social Care (UK)
•
2004 Medicines for Human Use (Clinical Trials) Regulations 2004 (UK)
•
2004 Human Tissue ACT 2004 (UK)
•
2005 EU Directive on Good Clinical Practice (2005/28/EC)
•
2005 Mental Capacity Act 2005 (UK)
Combining the strengths of UMIST and
The Victoria University of Manchester
caused a number
Why not just follow the law?
• Unethical laws
• Ethical issues not covered by law
• Law usually lags behind
• Laws set by precedent as well as legislation
• A proper understanding of the law requires
– Thinking for yourself
– That you make connections between different cases
– Judgement
– Ethical thinking
Combining the strengths of UMIST and
The Victoria University of Manchester
Laws cannot stipulate everything you must/
must not do.
The law is more likely to say that you MUST
act ethically.
Combining the strengths of UMIST and
The Victoria University of Manchester
Ethics
Ethics =
The science of human duty. The body of rules of
duty drawn from this science. A particular
system of principles and rules concerning
duty, whether true or false; rules of practice in
respect to a single class of human actions.
set of conventions
Not set in stone
Open to interpretation
Combining the strengths of UMIST and
The Victoria University of Manchester
What is unethical?
Technology ethics
• Excessive claims for the technology
Marketing hype?
ethical oversight or deliberate omission?
Medical ethics
• Negligence =
“conduct that falls short of the standards expected of a
person where a duty of care is owed and which causes
foreseeable damage to another person” Peter De Cruz,
Nutshell Medical Law
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The Victoria University of Manchester
Ethical standards vary
– Foreseeable damage
– Expected standards
– Duty of care
– Example:
Unhealthy drink, full of sugar and fat, marketed as a
sports/energy drink on TV
Same drink endorsed by a medical doctor on TV
Is one more unethical than the other?
Combining the strengths of UMIST and
The Victoria University of Manchester
Ethical conduct
• conforming to accepted standards of social or
professional behaviour
• “being a professional”
– Expected standards
– Duty of care
– Foreseeable impact/damage
Combining the strengths of UMIST and
The Victoria University of Manchester
Research Ethics
Conventions safeguarding the rights, dignity and
welfare of people participating in research
= conventions on “Being a professional”
– Doing more than what is required by law/ in your job
description
– Considering the impact of what you do
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The Victoria University of Manchester
Purpose of Research Ethics review
• Research which contravenes ethical conventions or has
not been ethically approved is
– Unacceptable to society
– Unacceptable to funding bodies
– Open to legal challenge by an aggrieved participant
Combining the strengths of UMIST and
The Victoria University of Manchester
Principles
of
Ethics
• Autonomy
– The participant must be free to choose (no coercion) or refuse
participation, without any adverse effect
• Beneficence
– The research must be worthwhile in itself. Its potential benefits
must outweigh any risks. The methodology must be sound so
that robust results will be yielded
• Non-maleficence
– Any possible harm must be avoided or mitigated by robust
precautions
• Confidentiality
– The right of the participant and his/her data to remain unknown
to all but the research team must be respected (unless
participant agrees otherwise
• Integrity
– The researcher must be open about any gains he/she makes
from the research
Combining the strengths of UMIST and
The Victoria University of Manchester
What type of non-medical research
needs ethical approval?
• Research which ‘uses’ human beings for the benefit of the
researcher, the community or society, with little or no direct benefit to
the individual subject, but with the possibility of harm, discomfort or
inconvenience to that individual
• Research is potentially beneficial but not inherently so: requires risk/
benefit analysis
Human tissue and data
– Foreseeable damage
– Expected standards
– Duty of care
Interaction with adults,
vulnerable adults, children
Interviews, (incl. via
telephone)
focus groups,
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Questionnaires (incl. via
telephone)
– Life Sciences
– Technology/engineering: testing appliances with/on
people (incl. simulations)
– Social Sciences
– Linguistics
– Management and Business studies
– Education
Combining the strengths of UMIST and
The Victoria University of Manchester
What is reviewed?
• Research Quality
– Is research justified? Is research question sound?
– Is research methodology sound?
• Research participants
– How are they recruited? Any coercion or pressure?
– Inclusion/exclusion criteria
– Remuneration/expenses vs enticement
– Hazards, dangers, discomfort, disturbance involved
– What steps have been taken to minimise risks / cover
possibility of an untoward event (appropriate back-up)
– How is confidentiality ensured? When/why might it be
broken?
Combining the strengths of UMIST and
The Victoria University of Manchester
What is reviewed?
• Information sheet
– must be sufficiently comprehensive and written in
appropriate language
– Must explain who you are, why research is being done,
what the participants’ involvement will be, what the
objectives are
– Must explain where they can turn for additional
information/help, what will happen if things go wrong
– Must state that free to take part and free to withdraw
without negative consequences
Combining the strengths of UMIST and
The Victoria University of Manchester
What is reviewed?
• Consent form
– Consent must be positive. The assumption that lack of
response means consent is unacceptable
– The right to withdraw without explanation should be
repeated
– Where children are involved, consent should be given
both by the parent/carer and the child and consent form
needs to be in a format appropriate to age or
educational development
– Vulnerable adults, arrangements for consent or assent.
Must be appropriate to target group (e.g. cognitively
impaired)
Combining the strengths of UMIST and
The Victoria University of Manchester
What else is reviewed?
• Sponsorship
• Indemnity arrangements
• Funding
Combining the strengths of UMIST and
The Victoria University of Manchester
Two Approval routes for Research Involving
Human Beings
NHS involvement
No NHS involvement
Staff, patients or facilities
Ethics review by NHS REC
committee (NRES / IRAS route)
Ethics review by University
Research Ethics Committee
R&D approvals from all Trusts
involved
Contracts
Sponsorship arrangements
/Contracts (incl. MTAs)
Other approvals
Indemnity arrangements
Combining the strengths of UMIST and
The Victoria University of Manchester
Other approvals
Indemnity arrangements
Contact details:
Karen Schafheutle, Research Practice &
Governance Co-ordinator
Research Office, Christie Building, The University of
Manchester M13 9PL
Tel: 0161 275 7583
Email: [email protected]
Combining the strengths of UMIST and
The Victoria University of Manchester